Safety Requirements for the First Use of New Drugs and Diagnostic Agents in Man: A Review of Safety Issues in Early Clinical Trials of Drugs
Geneva, Switzerland: Council for International Organizations of Medical Sciences [CIOMS], 1983. 61 p.
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Guidelines on Requirements for First-in-Man Clinical Trials for Potential High-Risk Medicinal Products. Released for Consultation 2007 March 22 Unknown author (European Medicines Agency. Committee for Medicinal Products for Human Use [CHMP], 2007-03-23)